Label: OLOPATADINE HYDROCHLORIDE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 10, 2023

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  • Drug Facts

    Active ingredient
    Olopatadine (0.2%)
    (equivalent to olopatadine hydrochloride, USP 0.222%)

  • Purpose

    Antihistamine

  • Use

    temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

  • Warnings

    For external use only

  • Do not use

    • if solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
    • to treat contact lens related irritation
  • When using this product

    • do not touch tip of container to any surface to avoid contamination
    • remove contact lenses before use
    • wait at least 10 minutes before reinserting contact lenses after use
    • do not wear a contact lens if your eye is red
  • Stop use and ask a doctor if you experience:

    • eye pain
    • changes in vision
    • increased redness of the eye
    • itching worsens or lasts for more than 72 hours
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    • adults and children 2 years of age and older:
      • put 1 drop in the affected eye(s) once daily, no more than once per day
      • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
      • replace cap after each use
    • children under 2 years of age:

        consult a doctor

  • Other information

    • only for use in the eye
    • store between 2° to 25°C (36° to 77°F)
  • Inactive ingredients

    benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection

  • Questions?

    ✆1-855-274-4122

    Distributed By
    AmerisourceBergen
    1 West First Avenue
    Conshohocken, PA 1942

    Made in India
    Code: TS/DRUGS/13/2010

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

    GOOD
    NEIGHBOR
    PHARMACY®                             NDC 46122-671-27
    Olopatadine Hydrochloride
    Ophthalmic Solution USP, 0.2%
    Antihistamine
                                                         Eye Allergy Relief
    STERILE                             2.5 mL (0.085 FL OZ)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

                                                      *Compare to the Active Ingredient
                                                             in Pataday® Once Daily Relief
    GOOD
    NEIGHBOR
    PHARMACY®                             NDC 46122-671-27
    NOW AVAILABLE without a prescription
    Olopatadine Hydrochloride
    Ophthalmic Solution, USP
    0.2%
    Antihistamine
                                          Eye Allergy Relief
    Works in Minutes
    Relief from Allergens:
    • Pet Dander • Pollen                     ONCE
    • Grass • Ragweed                          DAILY
    STERILE
    2.5 mL (0.085 FL OZ)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-671
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-671-271 in 1 CARTON01/19/2021
    12.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20999501/19/2021
    Labeler - Amerisource Bergen (007914906)
    Registrant - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eugia Pharma Specialities Limited650498244ANALYSIS(46122-671) , MANUFACTURE(46122-671)
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